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NEW EVIDENCE
EXHIBIT K

FEDERAL REGISTER / VOL. 67, NO. 85, MAY 2, 2002 / RULES AND
REGULATIONS - PAGE 22300-IIl. SUMMARY OF PUBLIC COMMENTS - B.
COMPENSABILITY

Federal Register/Vol.67, No. 85, May 2, 2002 / Rules and Regulations — Page 22300-II.
Summary of Public Comments — B... Compensability — This states in part: “Various
comments relating to the use of these guidelines were received. Specifically, HHS
received comments on: awarding compensation based upon a proportional level of
probability of causation; the use of the upper 99 percent confidence limit to estimate
probability of causation; awarding compensation for employees who incurred radiation
doses within regulated radiation safety limits; automatically ualifying employees who
incurred doses in excess of the maximum allowable radiation dose under Atomic Energy
Commission regulations; waiving dose reconstruction and probability of causation for
employees with rare cancers; and automatically compensating employees for whom DOE
is unwilling or unable to provide employment records. The development and use of these
guidelines for determining compensability and the benefit structure are statutorily
mandated and therefore these comments were not adopted.”

According to Dose Reconstruction Overview of the NIOSH Report of Dose
Reconstruction approved by NJOSH April 1, 2004 and sent to me in letter dated April 19,
2004 from Mr. Larry J. Elliott, “The Department of Labor (DOL) has verified that ~
worked at the Mathieson Chemical Company from 1949 through 1979 and
No

dosimetry or bioassay records for Telated to Mathieson Chemical’s work for
the Atomic Energy Commission, one of the predecessor agencies of the present
Department of Energy), could be found. Mathieson Chemical Company performed work
for the AEC between 1951 and 1953. The primary source of information used for this
dose reconstruction was the document “Technical Information Bulletin: Technical Basis
for Estimating the Maximum Plausible Dose to Workers at Atomic Weapons Employer
Facilities” prepared for the EEOICPA project.” No other records were provided. The
absence of records and the lack of known activities clearly show that dose reconstruction
is not feasible.
Attachment:

(1) Federal Register / Vol. 67, No. 85, May 2, 2002 / Rules and Regulations —

Page 22300-II.


22300

Federal Register/Vol. 67, No. 85/Thursday, May 2, 2002/Rules and Regulations

An initial version of the NIOSH-IREP
Operating Guide is available to the
public online on the NIOSH homepage
at: www.cde.gov/niosh/acas/ocosirep/
html. The public can obtain printed
copies by contacting NIOSH at its toll-
freo telephone information service: 1—
800-35-NIOSH (1-800-356-4674).

IL. Summary of Public Comments

On October 5, 2001, HHS proposed.
guidelines for determining probability
of causation under EEOICPA (42 CFR
81; see 66 FR 50967). HHS initially
solicited public comments from October
5 to December 4, 2001. The public
comment period was reopened
subsequently from January 17, 2002 to
January 23, 2002 for public comments,
and from January 17, 2002 to February
6, 2002, for comments from the
Advisory Board on Radiation and
Worker Health (67 FR 2397).

HHS received comments from 12
organizations and 24 individuals.
Organizations commenting included
several labor unions representing DOE
workers, a community based
organization, an administrative office of
the University of California, several
DOE contractors, and several federal
agencies. A summary of these comments
and HHS responses is provided below.
‘These are organized hy general topical
area.

A. Appropriateness of Adopting
Compensotion Policy Used for Atomic
Veterans

One commenter requested
explanation of the appropriateness of
adapting existing compensation policy
for atomic veterans to a compensation.
program for nuclear weapons workers.
‘The comment appears to question
whether this existing policy for atomic
voterans is an appropriate starting point
from which to develop compensation
policy under EEOICPA. In the notice of
proposed rulemaking, HHS had
solicited public comment on whether it
had appropriately adapted
compensation policy for atomic veterans
to meet the needs of this workforce,
which has a substantially different
occupational and radiation exposure
experience.

Congress determined the veteran's
compensation policy as a starting point
for HHS. It did so by requiring the
determination of probability of
causation based on radiation doses and
tha use of the NIH Radioepidemiological
Tables, and by requiring that the cancer
covered in a claim he determined to be
“at least as likely as not” caused by
radiation doses incurred in the
performance of duty, based on the upper
99 percent credibility limit. These are

defining features of compensation
policy for atomic vetorans.

The public should also recognize that
the Radioepidemiological Tables
required years to initially develop and
then additional years to update (the
update is not completed). Without this
critical, highly sophisticated element
developed for the veterans’ program, it
would not have been possible to
establish and implement a policy for
nuclear weapons workers in a timely
fashion.

HHS adapted these policies for
nuclear weapons workers through two
prominent measures, discussed in the
notice of proposed rulemaking and
below. HHS included provisions to
allow NIOSH to adapt the cancer risk
models in the latest version of the NIH
Radioepidemiological Tables to reflect
the unique radiation exposure
experience of nuclear weapons workers.
And HHS established transparent,
objective procedures for DOL to handle
a variety of circumstances in which
various information relevant to
determining probability of causation
will be unknown. The majority of
comments received on this rule suggest
most commenters view as appropriate
the measures HHS has taken to adapt
existing compensation policy to this
new program.

B. Compensabilily

Various comments relating to the use
of these guidelines were received.
Specifically, HHS received comments
on: awarding compensation based upon
a proportional level of probability of
causation; the use of the upper 99
percent confidence limit to estimate
probability of causation; awarding
compensation for employees who
incurred radiation doses within
regulated radiation safety limits;
automatically qualifying employees who
incurred doses in excess of the
maximum allowable radiation dose
under Atomic Energy Commission

ulations; waiving dose reconstruction
and probability of causation for
employees with rare cancers; and
automatically compensating employees
for whom DOE is unwilling or unable to
provide employment records.

The development and use of these
guidelines for determining
compensability and the benefit structure
are statutorily mandated and therefore
these comments were not adopted.

One commenter suggested prohibiting
the use of probability of causation
findings as proof of fault in litigation.
This suggestion was not adopted
because prohibiting the use of
probahility of causation findings for
litigation purposes is not authorized by

the statute. However, because these
findings will be based on NIOSH dose
reconstructions, which will not always
produce complete or best estimates of
the actual doses received by an
individual, '* HHS does not believe
these findings should be used for any
purpose other than the adjudication of
claims under EEOICPA.

C. Need for Peer Review

Several commenters recommended
that HHS obtain peer review of the
cancer risk models that comprise
NIOSH-IREP, and of changes to
NIOSH-IREP, as it is updated based on
progress in the underlying sciences.
Several commenters recognized that the
Advisory Board on Radiatiou and
Worker Health is intended by HHS as
one means of obtaining such peer
review, but the commenters raised
concerns about whether the Board
would have sufficient expertise for this
purpose.

HHS recognizes the importance of
peer review. Consequently, as indicated
above, the National Cancer Institute
obtained peer review of IREP by the
National Research Council. NCI and
NIOSH have made modifications in
IREP consistent with this peer review.
NIOSH has also obtained peer-review by
independent subject matter experts of
changes developed by NIOSH to adapt
TREP to the experience of nuclear
weapons workers. These peer-reviews
are posted on the NIOSH website and
are also available to the public by

yest.

in addition, the Advisory Board on
Radiation and Worker Health will be
reviewing the cancer risk models in
NIOSH-IREP, as indicated above and in
the notice of proposed rulemaking.
Contrary to the public comments noted
above, HHS finds the Board has
appropriate expertise for such a review,
inchiding eminent physicians and
scientists from the field of health
physics. Moreover, the Board maintains
the option to commission additional
independent scientists to participate in
the Board’s review. HHS also bas the
option lo obtain additional peer reviews
by the National Academy of Sciences, as
recommended by some commenters.

Im response to comments
recommending peer review and to the
recommendations of the Advisory Board
on Radiation and Worker Health
discussed below, HHS has added a new
requirement to this rule to affirm the
commitment of HHS to involve the

11 Far explanation of these possible limitations of
NIOSH dose reconstructions, see the discussion
‘under “Il. Summary of Public Comments: A.
Purpose of the Rule” in the preamble of 42 CFR Part
82 (the HHS dose reconstruction rule).